Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Akorn, Inc.
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, I...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Compan...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. AL...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL ...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Ami...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distr...
Topical Drugs·0 affected·Apr 26, 2023
CriticalFDA
Gadget Island, Inc
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Oral Drugs·140 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: ...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurne...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Drugs·0 affected·Apr 26, 2023
CriticalFDA
Gadget Island, Inc
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 ...
Oral Drugs·628 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL ...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for rec...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, ...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) pack...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn O...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 6...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, St...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lak...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurn...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Supplements·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
CriticalFDA
Gadget Island, Inc
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Oral Drugs·18 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurn...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake ...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. AL...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031....
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company-...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Man...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. A...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx On...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Ep...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest...
Topical Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company,...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Apotex Corp.
Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bott...
Inhaled / Nasal Drugs·82,375 affected·Apr 26, 2023